跳至主要内容
临床试验/NCT07140263
NCT07140263Enrolling By Invitation不适用

CARE-MI: A Comprehensive Group Intervention for Psychosocial Personnel at Risk of Experiencing Symptoms of Post-traumatic Stress and/or Moral Injury Associated With Work-related Stress: Design, Implementation, and Efficacy

Universidad Complutense de Madrid1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2025年2月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
92
试验地点
1
主要终点
Change in posttraumatic stress symptoms

研究概览

简要总结

The objective of this randomized controlled trial is to evaluate the effectiveness of the CARE-MI group intervention in reducing symptoms of post-traumatic stress and moral injury in support staff working with individuals diagnosed with physical or mental health conditions (psychosocial personnel). The study also seeks to assess its impact on symptoms of anxiety and depression, as well as its potential to improve overall well-being.

We will conduct a multicomponent study involving several pre-existing teams from collaborating centers, allowing the intervention to be evaluated in different institutional settings. This is a multilevel randomized trial, with each group randomly assigned, through blinded allocation using a computer program, to either the intervention group or a wait-list control group. Participants will be assessed at three time points: pre-intervention, post-intervention, and at a 6-month.

This trial is part of a larger research project that includes several related studies. Each study addresses a specific population and/or intervention, but all share the overarching aim of Coping and adaptation for recovery from moral injury.

详细描述

There is growing evidence of high prevalence rates of emotional distress, including PTSD, anxiety, depression, and moral injury, among healthcare professionals, particularly those exposed to high emotional loads or critical care settings. Studies report PTSD rates ranging from 10% to 20%, and up to 30% in ICU staff (Carmassi et al., 2020). These figures increase significantly during large-scale crises such as pandemics. For instance, during the COVID-19 outbreak, rates of PTSD symptoms reached up to 54% among U.S. healthcare workers, along with 48% for depression and 30% for anxiety (Shechter et al., 2020). Similar findings were observed in Spain and China, with high moral injury prevalence associated with anxiety and depression symptoms.

Moral injury is particularly concerning in settings with staffing shortages, where professionals feel unable to provide adequate care (British Medical Association, 2021; Liberati et al., 2021). This scenario extends to the mental health support network, including social and psychological care teams. In Spain, significant rates of emotional exposure (36%) and workplace violence have been reported among technical and support staff (Benavides et al., 2024).

Although trauma-focused interventions have shown efficacy in treating PTSD, most evidence focuses on individual formats. Group interventions, however, offer a scalable, resource-efficient alternative, with promising outcomes reported for ACT, mindfulness, EMDR, and other trauma-informed approaches (Fogliato et al., 2022; Sanz et al., 2024).

Despite this evidence, few interventions are specifically adapted and evaluated for mental health and healthcare professionals in their specific work contexts. This trial addresses this gap by evaluating the CARE-MI protocol in real-world care settings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age 18 or older
  • •Be currently employed as healthcare or support staff at the time of the intervention
  • •Provide informed consent
  • •Be fluent in Spanish The intervention is offered under the assumption that individuals who voluntarily participate likely perceive a need for support and may benefit from the program. This approach promotes accessibility, prevention, and early intervention for healthcare professionals.

排除标准

  • •None explicitly defined; the program is designed to be inclusive and preventive. Participants with acute clinical risk (e.g., active psychosis or severe suicidal ideation) may be redirected to individual clinical care if needed.

研究组 & 干预措施

CARE MI

Experimental

CARE-MI is a trauma-informed integrative group intervention designed to reduce post-traumatic stress symptoms and moral injury in psychosocial personnel working with individuals with physical or mental health conditions.

干预措施: CARE MI (Behavioral)

Waiting list (Delayed CARE-MI)

Other

Participants assigned to the waiting list will receive the CARE-MI intervention after the experimental group completes the initial study period. During the waiting period, they will receive usual institutional support. This design allows for comparison between groups while ensuring that all participants eventually receive the CARE-MI program.

干预措施: CARE MI (Behavioral)

Waiting list (Delayed CARE-MI)

Other

Participants assigned to the waiting list will receive the CARE-MI intervention after the experimental group completes the initial study period. During the waiting period, they will receive usual institutional support. This design allows for comparison between groups while ensuring that all participants eventually receive the CARE-MI program.

干预措施: TAU: Treatment as usual (Behavioral)

结局指标

主要结局

Change in posttraumatic stress symptoms

时间窗: Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up

Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5; Blevins et al., 2015). Higher scores indicate greater PTSD symptoms.

Change in moral injury symptoms

时间窗: [Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up]

Healthcare Moral Injury Scale (HMIS; Fradley et al., under review). Higher scores indicate higher levels of moral injury.

次要结局

  • Change in depressive symptoms([Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up])
  • Change in perceived meaning at work(Time Frame: Baseline)
  • Change in openness to the future([Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up])
  • Change in anxiety symptoms([Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up])
  • Change in mental wellbeing([Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up])
  • Change in experiential avoidance([Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up])
  • Change in perceived ability to cope with trauma([Time Frame: Baseline, post-intervention (4 weeks), 6-month follow-up])
  • Satisfaction with the intervention([Time Frame: Post-intervention (4 weeks)])

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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